Safety and Efficacy Study of CC-486 in Subjects With Myelodysplastic Syndromes
Status:
Active, not recruiting
Trial end date:
2021-12-17
Target enrollment:
Participant gender:
Summary
Evaluate the safety and efficacy of oral azacitidne (CC-486) twice daily (BID) in subjects
with myelodysplastic syndromes who failed to achieve an objective response post injectable
hypomethylating agent (iHMA) treatment
Reason for removing the combination arm: Due to difficulties with dose-finding, the
durvalumab plus CC-486 combination arm was closed to enrollment.
Extension:
An Extension Phase (EP) has been added to allow subjects who are currently receiving oral
azacitidine BID and who are demonstrating clinical benefit as assessed by the Investigator,
to continue receiving oral azacitidine until the subject meets the criteria for study
discontinuation.